Events

CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATING BULB (PK10) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-00284-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00284-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer have identified that the boxes used to ship the products were too small for the number of products (10 units) packaged within the box. the units packed into the shipper experienced bending and folding of the pouches. this can increase the risk of breaching the outer pouch. note that only a breach in the exterior pouch was detected – the interior pouch was not breached. a breach would have to develop in both pouches before the product would become unsterile.
  • 조치
    Stryker is requesting their customer to discontinue use and quarantine the affected product. A Stryker Representative will organise for the removal of any affected units found and a credit will be given for these items.

Device

CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATIN...
  • 모델명 / 제조번호(시리얼번호)
    CBCII AMBULATING BULB (PK10), 1/8 TROCAR W/DRAIN (PK10), 1/4 TROCAR W/DRAIN (PK10)CBCII AMBULATING BULB (PK10)Catalogue Number: 0225028852Lot Numbers: 10337012, 102810121/8 TROCAR W/DRAIN (PK10)Catalogue Number: 0215018000Lot Numbers: 13191012, 11088012,11125012, 112040121/4 TROCAR W/DRAIN (PK10)Catalogue Number: 0215019000Lot Number: 12235012ARTG Numbers: 140544, 233315
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA